Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
Reaction products of 1-(substitutedphenyl)urea coupled with diazotated potassium sodium substituted-5-{[2-(substituted)ethyl]sulfonyl}benzenesulfonate, further condensed with 2,4,6-trichloro-1,3,5-triazine, further converted with disubstituted benzene-1,4-disulfonic acid in aq. sodium hydroxide
EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted between 14 April 2016 and 21 April 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Two male rabbits
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Leicestershire, UK.
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.53 or 2.73 kg
- Housing :individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs
IN-LIFE DATES: From: 14 April 2016 To: 21 April 2016
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in 74% industrial methylated spirits
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours
SCORING SYSTEM:
EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation
- No erythema : 0
- Very slight erythema (barely perceptible): 1
- Well-defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Edema Formation
- No edema: 0
- Very slight edema (barely perceptible): 1
- Slight edema (edges of area well-defined by definite raising): 2
- Moderate edema (raised approximately 1 millimeter): 3
- Severe edema (raised more than 1 millimeter and extending beyond the area of exposure): 4
Any other skin reactions and clinical signs of toxicity, if present, were also recorded.
An additional observation was made on Day 7 to assess the reversibility of skin reactions.
Individual body weights were recorded on Day 0 (the day of dosing) and at the end of the observation period.
DATA EVALUATION
The scores for erythema and edema at the 24 and 72 Hour readings were totaled for the two test rabbits (8 values) and this total was divided by 4 to give the primary irritation index of the test item. The test item was classified according to the following scheme devised by Draize, J.H. (1959):
- Method of calculation: Draize, J.H. (1959)
Primary Irritation Index Classification of Irritancy
0 Non-irritant
> 0 to 2 Mild irritant
> 2 to 5 Moderate irritant
> 5 to 8 Severe irritant
If irreversible alteration of the dermal tissue is noted in any rabbit, as judged by the Study Director, which include ulceration and clear necrosis or signs of scar tissue, the test item is classified as corrosive to rabbit skin. Classification according to Draize may, therefore, not be applicable.
The results were also interpreted according to the Globally Harmonized System of Classification and Labelling of Chemicals.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: Immediately
- Score:
- 0
- Remarks on result:
- other: Orange colored staining of the test site
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 0
- Remarks on result:
- other: Orange colored staining of the test site
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Orange colored staining of the test site
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Orange colored staining of the test site, Loss of skin elasticity
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Orange colored staining of the test site, Loss of skin elasticity, Loss of skin flexibility
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: Immediately
- Score:
- 0
- Remarks on result:
- other: Orange colored staining of the test site
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 0
- Remarks on result:
- other: Orange colored staining of the test site
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Orange colored staining of the test site
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Orange colored staining of the test site, Loss of skin elasticity
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Orange colored staining of the test site, Loss of skin elasticity, Loss of skin flexibility
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: Immediately
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: Immediately
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 1 and 2
- Time point:
- other: 24 and 72 Hours
- Score:
- 15
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 3.8
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- The test item produced a primary irritation index of 3.8 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Well-defined erythema and slight edema were noted at both treated skin sites at the 24 and 48 Hour observations with well-defined erythema and very slight to slight edema noted at the 72 Hour observation.
Both treated skin sites appeared normal at the 7-Day observation. - Other effects:
- - Other adverse local effects: Loss of skin flexibility and/or elasticity was noted at both treated skin sites at the 48 and 72 Hour observations. Both treated skin sites appeared normal at the 7-Day observation.
- Other adverse systemic effects: One animal showed body weight loss and the other animal showed expected gain in body weight during the study.
Any other information on results incl. tables
Orange colored staining of the test site, not preventing evaluation of skin responses, was noted at both treated skin sites during the study. The test substance is a dark orange powder.
Individual Skin Reactions
Skin Reaction |
Observation Time |
Individual Scores |
Total |
|
Rabbit Number and Sex |
||||
75409Male |
75412Male |
|||
Erythema/Eschar Formation |
Immediately |
0STA |
0STA |
(0 ) |
1 Hour |
0STA |
0STA |
( 0 ) |
|
24 Hours |
2STA |
2STA |
4 |
|
48 Hours |
2STALe |
2STALe |
( 4 ) |
|
72 Hours |
2STALeLf |
2STALeLf |
4 |
|
7 Days |
0 |
0 |
( 0 ) |
|
Edema Formation |
Immediately |
0 |
0 |
( 0 ) |
1 Hour |
0 |
0 |
( 0 ) |
|
24 Hours |
2 |
2 |
4 |
|
48 Hours |
2 |
2 |
( 4 ) |
|
72 Hours |
2 |
1 |
3 |
|
7 Days |
0 |
0 |
( 0 ) |
|
Sum of 24 and 72‑Hour Readings (S) : 15 |
||||
Primary Irritation Index (S/4) : 15/4 = 3.8 |
||||
Classification : MODERATEIRRITANT |
( ) = Total values not used for calculation of primary irritation index
STA = Orange colored staining of the test site
Le = Loss of skin of elasticity
Lf = Loss of skin flexibility
Individual Body Weights and Body Weight Change
Rabbit Number |
Individual Body Weight (kg) |
Body Weight Change (kg) |
|
Day 0 |
Day 7 |
||
75409Male |
2.73 |
2.84 |
0.11 |
75412Male |
2.53 |
2.50 |
-0.03 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item produced a primary irritation index of 3.8 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. however, the test item was classified as non irritant according to the Globally Harmonized System of Classification and Labelling of Chemicals, since the effects found were fully reversible by the end of 7 days and mean scores for erythema and edema were <2.3.
- Executive summary:
Introduction
The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit.
Results
A single 4‑Hour, semi‑occluded application of the test item to the intact skin of two rabbits produced well-defined erythema, slight edema and loss of skin elasticity and flexibility. Both treated skin sites appeared normal at the 7‑Day observation.
Conclusion
The test item produced a primary irritation index of¨3.8 and was classified as amoderateirritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. However, the test item was classified as non irritant according to the Globally Harmonized System of Classification and Labelling of Chemicals, since the effects found were fully reversible by the end of 7 days and mean scores for erythema and edema were <2.3.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Embora a ECHA disponibilize muito material em linha na sua língua, uma parte desta página está disponível apenas em inglês. Mais informações sobreas práticas de multilinguismo da ECHA.
Bem-vindo ao sítio Web da ECHA O navegador Internet Explorer 7 (e versões anteriores) não é totalmente suportado por este sítio Web. Por favor atualize o seu Internet Explorer para uma versão mais recente.
Este sítio Web utiliza cookies a fim de garantir a melhor experiência possível nos nossos sítios Web.
Saiba mais sobre como utilizar cookies.